1. FDLI Introduction to Medical Device Law and Regulation Other Postmarket Controls Philip Katz (202) 624-2660 pkatz@crowell.com October 29, 2002 Washington, D.C.

2. 2 Device Tracking n FDCA § 519(e) n 21 CFR Part 821 (amended effective May 9, 2002) n “Guidance on Medical Device Tracking” (Jan. 2000)

3. 3 FDCA § 519(e) n Class II or III device l Failure likely to have serious adverse health consequences l Intended to be implanted for more than one year l Life sustaining/supporting device used outside device user facility

4. 4 Additional Factors n Likelihood of sudden, catastrophic failure n Likelihood of significant adverse clinical outcome n Need for prompt professional intervention

5. 5 Device Tracking n To ensure that device can be traced from manufacturing facility to patient n Must be able to locate device quickly l Three days for undistributed device l Ten days for device distributed to patient

6. 6 Device Tracking n Separate order issued with PMA approval or 510(k) clearance n Methods may vary, but must have written SOPs n Can use outside contractor

7. 7 Device Tracking n Must audit system, to verify that it works and the information is accurate n Must maintain records as long as device is in distribution or use

8. 8 Device Tracking n Distributors (such as hospitals and other user facilities) must track and provide information to the manufacturer n Obligations start/stop at water’s edge n Patient can refuse identifying information

9. 9 Postmarket Surveillance n FDCA § 522 n 21 CFR Part 822 (effective July 8, 2002) n “Guidance on Criteria and Approaches for Postmarket Surveillance” (Nov. 1998)

10. 10 FDCA § 522 n Class II or III device l Failure likely to have serious adverse health consequences l Intended to be implanted for more than one year l Life sustaining/supporting device used outside device user facility

11. 11 Other Criteria n Important unanswered surveillance question n Availability of other postmarket mechanisms n Practicality of surveillance strategies n Magnitude of risk

12. 12 Postmarket Surveillance n Limitations of premarket data n Shortcomings of MDRs

13. 13 Postmarket Surveillance n Required by FDA order, not necessarily at time of review/clearance n Manufacturer must submit plan in 30 days n FDA has 60 days to judge plan’s adequacy

14. 14 Range of Methods n Literature review n Secondary data sets, registries n Studies (clinical, non-clinical)

15. 15 Postmarket Surveillance n Can last up to three years n Applies to foreign manufacturers n Does not apply to devices for export only n Informed consent and IRB requirements apply

16. 16 Postmarket Surveillance n Interim and final reports n Retain records for two years n Produce records within three days n Records subject to inspection/review

17. 17 Device Promotion n Advertising l Not defined, but see drug regulations n Labeling l Label and “all other written, printed or graphic matter... accompanying” the device

18. 18 Device Promotion n Misleading l FDCA § 201(n) l Not just representations made or suggested, but also material omissions

19. 19 FDCA § 502 – Misbranding n All devices l False or misleading labeling (FDCA § 502(a)) l Adequate directions for use, adequate warnings (FDCA § 502(f)) l Registration, listing, 510(f) notice/information (FDCA § 502(o))

20. 20 FDCA § 502 – Misbranding n Restricted devices l False or misleading advertising (FDCA § 502(q)) l Advertising or “other descriptive matter” lacks side effects, contraindications (FDCA § 502(r))

21. 21 Device Promotion n Unapproved uses n False or misleading statements

22. 22 Unapproved Uses n Promotion of device that is not approved or cleared n Promotion of cleared/approved device for use that is not cleared or approved n Not limited to advertising/labeling

23. 23 False or Misleading Statements n Shared jurisdiction l FDA – all labeling, restricted device ads l FTC – all other device ads l Sort of

24. 24 False or Misleading Statements n Jurisdiction makes a difference l Different outlooks l Different processes l Different results

25. 25 False or Misleading Statements n FDA l No clear standard l Can look to drug ad regulations l Can look to FTC

26. 26 False or Misleading Statements n FTC l Identifying the representation l Determine whether it’s true and substantiated

27. 27 FTC n Identify the representation l Express and implied claims l Intent irrelevant l Reasonable interpretation by target audience

28. 28 FTC n Is the claim true and substantiated? l Implied presence of substantiation l “Establishment” claims l True + false = false

29. 29 Other Issues n Internet n First Amendment

30. FDLI Introduction to Medical Device Law and Regulation Other Postmarket Controls Philip Katz (202) 624-2660 pkatz@crowell.com October 29, 2002 Washington, D.C.